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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.96 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Read across statement for toxicological and ecotoxicological endpoints

 

Depending on the raw material source (in nature occurring natural oils and fats) Fatty acid methyl esters can vary in their chain length distribution. Such products are typical UVCB substances. Nevertheless the toxicological and ecotoxicological profile derive from the individual components within the UVCB. In order to avoid extensive testing and duplication of animal tests the industry took the approach to test a representative Fatty acid methyl ester, Fatty acid, C16-C18 and C18-unsatd., me esters (EC 267-015-4; CAS 67762-38-3), with a broad chain length distribution and read across the test results to Fatty acids, vegetable-oil, Me esters (EC 273-606-8; CAS 68990-52-3).

___________________________________________________________________________________________

Acute toxicity

The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified for acute toxicity hazards, no acute DNELs need to be calculated.

Local effects

Since no local effects were described, the DNELs are based on the systemic effects only.

LONG -TERM DNEL

The long-term DNEL is based on the most critical NOAEL seen in the repeated/ reproduction study with a NOAEL of 1000 mg/kg.

long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) =

1000 * (1/ sRV(a) * 0.67 (b) )

--------------------------------------------------------------------------------------------------------------------------- =

                                               25 (c)

 

1000* (1/ 0.384) * 0.67

--------------------------------------------------------              = .6.96 mg/m3

                      25

(a) Standard respiratory volume (sRV) rat:0.384 m3/kg

(b) correction for worker respiratory volume (conservative default for route to route)

(c)interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 5 * 2 )

 

 

long-term DNEL for the dermal route (systemic effects, route to-route extrapolation)

1000 *1 (a) / 4*2.5*5 (b) *2 (c) = 10 mg/kg bw/day

(a) route to route extrapolation oral to dermal

(b) assessment factors (interspecies * intraspecies (4*2.5) * 5)

(c) Correction for duration from subacute to chronic (2)

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Acute toxicity

The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified for acute toxicity hazards, no acute DNELs need to be calculated.

Local effects

Since no local effects were described, the DNELs are based on the systemic effects only.

LONG -TERM DNEL

The long-term DNEL is based on the most critical NOAEL seen in the repeated/ reproduction studywith a NOAEL of 1000 mg/kg.

long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) =

1000 * (1/ sRV(a))

--------------------------------------------------------------------------------------------------------------------------- =

                                               2.5*10*2 (b)

 

1000* (1/ 1.15)

--------------------------------------------------------              = 23 mg /m3

                50

(a) Standard respiratory volume (sRV) rat for general public (24h):1.15 m3/kg

(b) Interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 10 * 2 )

 

long-term DNEL for the dermal route (systemic effects, route to-route extrapolation)

1000 *1 (a) / 4*2.5*5 (b) *2 (c) = 5.01 mg/kg bw/day

(a) route to route extrapolation oral to dermal

(b) assessment factors (interspecies * intraspecies (4*2.5) * 10)

(c) Correction for duration from subchronic to chronic (2)

long-term DNEL for the oral route (systemic effects)

1000 / 4*2.5*5 (a) *2(b) = 5.01 mg/kg bw/day

(a) assessment factors (interspecies * intraspecies (4*2.5) * 10)

(b) Correction for duration from subchronic to chronic (2)